Klinischer Monitor / Clinical Research Associate / CRA (m/w/d) Home Office based
ClinSol GmbH & Co. KG
Die ClinSol GmbH & Co. KG ist eine junge und aufstrebende Firma in den Bereichen klinische Auftragsforschung, im Rahmen nationaler & internationaler Studienprojekte, und Medical Education. Aufgaben Organisation, Koordination und Monitoring klinischer Studien gemäß ICH- und GCP-Richtlinien sowie interner SOPs Rekrutierung, Selektion und Training von Prüfärzten und Studienzentren Durchführung der Studieninitiierung, des Routine-Monitorings (on-site / remote) und des Abschlussbesuchs an deutschlandweiten Prüfzentren einschließlich Zentrumskommunikation und schriftlicher Dokumentation Identifizierung von Problemen vor Ort und Eskalation an den Studiensponsor Konzeptionierung und Einreichung der Unterlagen bei Ethikkommissionen und Bundesoberbehörden sowie Unterstützung bei der Korrespondenz Termin- und Fristenüberwachung Pflege von Studiendaten in Datenbanken (Access, Excel) Unterstützung bei Einreichungstätigkeiten / Führen des TMF Qualifikation mind. 1 Jahr Erfahrung als klinischer Monitor Sehr gute ICH-GCP- und AMG-Kenntnisse Sehr gute PC-Anwenderkenntnisse (MS-Office) Gute Englischkenntnisse in Wort und Schrift Sehr gute Organisationsfähigkeit, Selbständigkeit, Flexibilität, Zuverlässigkeit, ausgeprägter Teamgeist, Kommunikationsfähigkeit und Aufgeschlossenheit Idealerweise Kenntnisse im Bereich Monitoring onkologischer Studien Benefits Wir bieten Ihnen eine abwechslungsreiche und interessante Tätigkeit in einem wachsenden Unternehmen sowie einen sicheren Arbeitsplatz. #J-18808-Ljbffr ClinSol GmbH & Co. KG
Vacancy posted 2 days ago
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